QUALITY RISK MANAGEMENT (QRM) OF ACTIVE PHARMACEUTICAL INGREDIENTS DURING TRANSPORTATION BY USING FMEA TOOLS AND METHODOLOGY

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ABOUT AUTHORS
UPENDRA KUMAR SINGH*, Mr. Sammer Rastogi, Dr. Manish Kumar Yadav
*MASTER OF PHARMACY in QUALITY ASSURANCE
School of Pharmacy, Lloyd Institute of Management and Technology
Uttar Pradesh, India
* upendra.singh81@gmail.com

ABSTRACT Quality Risk Management (QRM) is a key component for access the product quality. For any pharmaceutical product, Quality Risk Management shall be applied to aim that raising the level of protection for the patient by the reduction of the risk to which that patient is exposed at the time he /she receives a drug product. This general objective can only be achieved by implemented policy of Quality Risk Management (QRM) on the product and process design and its lifecycle. The concept of risk management was first applied in the financial and insurance sectors. This concept was systematically transferred and applied in the pharmaceutical industries in 2005 with the International Conference on Harmonization (ICH) and its publication of the ICH guideline Q9 on “Quality Risk Management”. The European Commission added this guideline as Annex 20 to the EU GMP guide in March 2008. This research was explored the risk identification, risk assessment and development scientific risk control measures during transportation of API from API manufacturing site to user site (formulation plant).

Reference Id: PHARMATUTOR-ART-2530

PharmaTutor (Print-ISSN: 2394 - 6679; e-ISSN: 2347 - 7881)

Volume 5, Issue 10

Received On: 16/06/2017; Accepted On: 23/06/2017; Published On: 01/10/2017

How to cite this article: Singh UK, Rastogi S, Yadav MK; Quality Risk Management (QRM) of active pharmaceutical ingredients during transportation by using FMEA tools and methodology; PharmaTutor; 2017; 5(10); 23-29

INTRODUCTION
Risk is defined as a combination of the probability that damage will occurs and the extent of that damage. These researches are describing that to lay down a procedure to identify failure modes and analyze, assess & control the risk associated with transportation of API from API manufacturing site to user site (formulation plant). Risk Management is done through scientific approach in order to achieve quality of product and to prevent of the entry of falsified drug in drug product & control measures and monitoring during transportation of Active Pharmaceutical Ingredients.

RISK ASSESSMENT APPROACH
The risk based approach is a basic element of the revised EU GMP guidelines on “Principle of Good Distribution Practice of active substances for medicinal products for human use”.
Quality risk management should ensure that the evaluation of risk to quality is based on scientific knowledge and experience with the process. Failure Modes and Effects Analysis (FMEA) is proactive method for evaluating a drug product to identify where and how it might impact and to assess the relative impact of different failures, in order to identify the parts of the process that are most in need of change. FMEA includes review of the following:
• Failure modes (What could go wrong?)
• Failure causes (Why would the failure happen?)
• Failure effects (What would be the consequences of each failure?)

 

Risk analysis is performed into the following process steps:
• Risk Assessment: Risk analysis
• Risk Control: Risk acceptance
• Risk Review: Processes and procedure


Figure 1: Overview of a typical quality risk management process

Methodology for risk Analysis and evaluation of risk in the supply chain transport:
By applying the FMEA tool and methodology the following aspects are evaluated to assess the risk and evaluation of risk during transportation of API from API manufacturing site to user site (formulation plant site).

• Determine which functions represent potential “Failure Modes” or points of potential failure.
• Determine the worst potential “Effect” or consequences of each of the failure modes.
• Determine the “Contributory Factors” for each failure mode
• Identify any “Controls” in the transportation method / process. Controls are components of the process which (a) reduce the likelihood of a contributory factor or a failure mode, (b) reduce the severity of an effect, or (c) detect the occurrence of a Failure Mode or Contributory Factor before it leads to the adverse outcome (Effect). Example of control measure is: Good Distribution Practices (GDP), validated transport, Assign transportation controls and alarm systems for temperature excursion.
• Rate of severity (consequences of failure) (S), Probability of occurrence (likelihood) (O) and  rate the effectiveness of each “Detection Control” (D) details is given in term of degree in the below table 1 “ Degree of Risk Ranking”.
• Calculate the Risk Priority Number (RPN) as per below;
RPN = S x O x D
• The product of three rating is the Risk Priority Number (RPN) for that Contributory Factor e.g. If severity rating is 3, occurrence rating is 2 and detection level is 1, then RPN=3×2×1=6
• Calculate the overall Risk Priority Number (RPN) by addition of each failure mode Risk Priority Number.

• Calculate the  Risk Assessment rating by assigning Risk Level (RL) as follows:
        Sum of RPN for each failure mode
RL = ------------------------------------------------------x 100

      Sum of highest RPN for each failure mode (920)#

#calculated as per highest RPN for each failure mode in table 1 degree of risk ranking(5x5x5+5x5x5+5x5x5+5x5x5+5x5x5+5x5x5+5x5x5+3x5x3) = 920

• API shall be chosen as per Risk Level Rating  for consequences-
a) RL ≥ 70 %:  Severe – API shall not be used for drug product manufacturing and supply is hold & intimate to vendor for  CAPA implemented
b) 50 % <RL  <70 % : Major – Risk reduction shall be done additional control implementation during transportation
c) 25 % <RL < 50 %: Moderate – Manage by routine monitoring process
d) Less than 25 %: Minor – No action required, risk is adequate and acceptable.

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